Dry EyeNCT05911555
Mucin Levels in Dry Eye and Normal Populations
An observational study of Dry Eye, run by ORA, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate changes in ocular mucin levels in response to a drying environment in subjects with dry eye disease as well as patients who report no history of dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with dry eye will be selected from a previous trial and subjects without dry eye will be also be enrolled.
Who may be able to join
- Be male or female of any race, at least 18 years of age at Visit 1.
- Have provided verbal and written informed consent.
- Have a best corrected visual acuity of +0.70 logMAR or better in both eyes at Visit 1, as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
- If a woman of childbearing potential, have a negative urine pregnancy test at Visit 1 and agree to use a medically acceptable form of birth control throughout the study duration . [Females are considered of childbearing potential unless they are surgically sterilized (bilateral tubal ligation, hysterectomy or bilateral oophorectomy) or post-menopausal (at least 12 months since last menses).]
- Have previously completed a recent trial OR not completed a recent trial AND report no symptoms of dry eye disease.
Who cannot join
- Have planned surgery during trial period
- Female currently pregnant, planning a pregnancy or lactating
- Use of disallowed medications
- Have ocular infections, or ocular conditions that could affect study parameters
- Have used an investigational drug or device within 30 days of start of study
- Female that is currently pregnant, planning a pregnancy or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: A Single-Center Pilot Study To Evaluate the Effects of a Challenge Model on Mucin 16 Levels in Dry Eye Subjects Compared to Normal Subjects
The purpose of this study is to evaluate changes in ocular mucin levels in response to a drying environment in subjects with dry eye disease as well as patients who report no history of dry eye disease.
It is expected that exposure to the dry environment will alter mucin levels in different ways when comparing the two groups.
Read the detailed description
This is a single-center, two visit, pilot, drying environment study (CAE). There will be two different groups of subjects enrolled into this study: dry eye subjects and subjects with no prior diagnosis of dry eye.
All subjects will undergo safety and dry eye assessments as well as tear collection prior to and after being exposed to a dry environment. They will also return the following day to undergo dry eye assessments, tear collection, and safety procedures again.
- Conditions
- Dry Eye
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-Dry Eye Subjects | Subjects with no reported history of dry eye disease will be enrolled | |
| Dry Eye Disease | Subjects who have been diagnosed with dry eye disease in a previous trial will be enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucin levels assayed from collected tears
Tears will be collected and mucin will be measured after subjects are exposed to the CAE.
Measured: 10-30 minutes Post CAE at Visit 1
Mucin levels assayed from collected tears
Tears will be collected and mucin will be measured 24 hours after being exposed to the CAE.
Measured: 24 hours after being exposed to the CAE
Secondary outcomes (22)
Fluorescein staining
staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales
Measured: pre-CAE
Fluorescein staining
Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales
Measured: 10-30 minutes Post CAE
Fluorescein staining
Staining will be measured measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales
Measured: 24 hours post-CAE
Lissamine staining
Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales
Measured: pre-CAE
Lissamine staining
Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales
Measured: 10-30 minutes Post CAE
Lissamine staining
Staining will be measured to detect presence of Superficial Punctate Keratitis and Confluency using Ora Calibra™ Corneal and Conjunctival Staining Scales
Measured: 24 hours post-CAE
Presence of conjunctival redness
conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale
Measured: pre-CAE
Presence of conjunctival redness
conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale
Measured: 10-30 minutes Post CAE
Presence of conjunctival redness
conjunctival redness will be assessed by Ora Calibra™ Conjunctival Redness Scale
Measured: 24 hours post-CAE
Tear Film Break Up Time
Tear Film Break Up Time
Measured: pre-CAE
Tear Film Break Up Time
Tear Film Break Up Time
Measured: 10-30 minutes Post CAE
Tear Film Break Up Time
Tear Film Break Up Time
Measured: 24 hours post-CAE
Blink Rate Analysis
Blink Rate Analysis
Measured: pre-CAE
Blink Rate Analysis
Blink Rate Analysis
Measured: 10-30 minutes Post CAE
Blink Rate Analysis
Blink Rate Analysis
Measured: 24 hours post-CAE
Symptom Collection
Symptom Collection
Measured: pre-CAE
Symptom Collection
Symptom Collection
Measured: 10-30 minutes Post CAE
Symptom Collection
Symptom Collection
Measured: 24 hours post-CAE
Ora Calibra Ocular Protection Index 2.0
Ora Calibra Ocular Protection Index 2.0
Measured: pre-CAE
Ora Calibra Ocular Protection Index 2.0
Ora Calibra Ocular Protection Index 2.0
Measured: 10-30 minutes Post CAE
Ora Calibra Ocular Protection Index 2.0
Ora Calibra Ocular Protection Index 2.0
Measured: 24 hours post-CAE
Schirmer's Test
Schirmer's Test
Measured: End of Visit 2 (Day 1 of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study startMay 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gail Torkildsen, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911555
- Sponsor's protocol ID
- 13-270-0004
- Status last verified
- Jun 2023
- First submitted
- 30 Jul 2013
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Pilot Study To Evaluate the Effects of a Challenge Model on Mucin 16 Levels in Dry Eye Subjects Compared to Normal Subjects
- ClinicalTrials.gov ID
- NCT05911555
- Acronym / sponsor ID
- 13-270-0004
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- ORA, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate changes in ocular mucin levels in response to a drying environment in subjects with dry eye disease as well as patients who report no history of dry eye disease.
It is expected that exposure to the dry environment will alter mucin levels in different ways when comparing the two groups.
Detailed description
This is a single-center, two visit, pilot, drying environment study (CAE). There will be two different groups of subjects enrolled into this study: dry eye subjects and subjects with no prior diagnosis of dry eye.
All subjects will undergo safety and dry eye assessments as well as tear collection prior to and after being exposed to a dry environment. They will also return the following day to undergo dry eye assessments, tear collection, and safety procedures again.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Dry Eye Subjects | – | –Subjects with no reported history of dry eye disease will be enrolled |
| Dry Eye Disease | – | –Subjects who have been diagnosed with dry eye disease in a previous trial will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with dry eye will be selected from a previous trial and subjects without dry eye will be also be enrolled.
Key inclusion criteria (5 listed)
- Be male or female of any race, at least 18 years of age at Visit 1.
- Have provided verbal and written informed consent.
- Have a best corrected visual acuity of +0.70 logMAR or better in both eyes at Visit 1, as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
- If a woman of childbearing potential, have a negative urine pregnancy test at Visit 1 and agree to use a medically acceptable form of birth control throughout the study duration . [Females are considered of childbearing potential unless they are surgically sterilized (bilateral tubal ligation, hysterectomy or bilateral oophorectomy) or post-menopausal (at least 12 months since last menses).]
- Have previously completed a recent trial OR not completed a recent trial AND report no symptoms of dry eye disease.
Key exclusion criteria (6 listed)
- Have planned surgery during trial period
- Female currently pregnant, planning a pregnancy or lactating
- Use of disallowed medications
- Have ocular infections, or ocular conditions that could affect study parameters
- Have used an investigational drug or device within 30 days of start of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mucin levels assayed from collected tears
Time frame: 10-30 minutes Post CAE at Visit 1
Tears will be collected and mucin will be measured after subjects are exposed to the CAE.
Mucin levels assayed from collected tears
Time frame: 24 hours after being exposed to the CAE
Tears will be collected and mucin will be measured 24 hours after being exposed to the CAE.
22 secondary outcomes
Fluorescein staining
Time frame: pre-CAE
Fluorescein staining
Time frame: 10-30 minutes Post CAE
Fluorescein staining
Time frame: 24 hours post-CAE
Lissamine staining
Time frame: pre-CAE
Lissamine staining
Time frame: 10-30 minutes Post CAE
Lissamine staining
Time frame: 24 hours post-CAE
Presence of conjunctival redness
Time frame: pre-CAE
Presence of conjunctival redness
Time frame: 10-30 minutes Post CAE
Presence of conjunctival redness
Time frame: 24 hours post-CAE
Tear Film Break Up Time
Time frame: pre-CAE
Tear Film Break Up Time
Time frame: 10-30 minutes Post CAE
Tear Film Break Up Time
Time frame: 24 hours post-CAE
Blink Rate Analysis
Time frame: pre-CAE
Blink Rate Analysis
Time frame: 10-30 minutes Post CAE
Blink Rate Analysis
Time frame: 24 hours post-CAE
Symptom Collection
Time frame: pre-CAE
Symptom Collection
Time frame: 10-30 minutes Post CAE
Symptom Collection
Time frame: 24 hours post-CAE
Ora Calibra Ocular Protection Index 2.0
Time frame: pre-CAE
Ora Calibra Ocular Protection Index 2.0
Time frame: 10-30 minutes Post CAE
Ora Calibra Ocular Protection Index 2.0
Time frame: 24 hours post-CAE
Schirmer's Test
Time frame: End of Visit 2 (Day 1 of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail Torkildsen, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by ORA, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucin levels assayed from collected tears (time frame: 10-30 minutes Post CAE at Visit 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.